Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions: nervous system disorder

Age:
Between 1 - 1 Years

Gender: Male or Female

Inclusion Criteria:

Male and female participants whose corrected gestational age is greater than or equal
to (>=) 52 weeks (gestational weeks plus the number of weeks after birth) and less
than (<) 18 years (and weight greater than [>] 5 kilogram [kg]), at the time of
investigational product administration. If the participant's exact age is not known,
the participant should be excluded.

Parent, guardian, or legally authorized representative (LAR) of the child provides
informed consent (and assent, when applicable per Shire policy and country
regulations) to participate in the study prior to participation in any protocol
specific procedures. The participant may be prescreened by the investigator in their
clinical practice and the parent, guardian, or LAR may sign informed consent before
the participant presents to the healthcare setting for treatment of the seizure.

Participant with generalized tonic-clonic SE with seizures accompanied by loss of
consciousness with any of the following characteristics persistent at the time of
study drug administration:

Currently presenting with seizure (convulsive) activity and 3 or more convulsions
within the preceding hour

Currently presenting with seizure (convulsive) and 2 or more convulsions in
succession without recovery of consciousness

Currently presenting with a single seizure (convulsive) lasting >=5 mins

Exclusion Criteria:

Female participants who are pregnant, suspected to be pregnant, or nursing.

Subjects with major trauma, not necessarily restricted to the head, as the cause of
the seizure.

Subjects with seizures due to illegal drug or acute alcoholic intoxication.

Subjects with known or suspected recurrent seizures due to illegal drug or alcohol
withdrawal.

Subjects with history of seizures of psychogenic origin.

Subjects with seizures due to severe encephalitis or meningitis, as determined by the
PI

Subjects with known history of hypersensitivities, non-responsiveness or
contraindications to benzodiazepines (ie, clinically significant respiratory
depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea,
glaucoma with closed angle, use of concomitant drugs determined by the investigator to
have a contraindication to the use of benzodiazepines.)

Subjects with a known history of benzodiazepine abuse.

Subjects who, in the judgment of the healthcare provider, have not responded to
previous administrations of midazolam systemic therapies, including Midafresa and/or
Dormicum.

Subjects who need emergent surgical intervention and general anesthesia/intubation.

Subjects with significant hypotension and cardiac dysrhythmia (example [eg],
atrioventricular [AV] block of second or third degree, VT [ventricular tachycardia]).